Improving product reliability may be the primary objective of reliability analysis; yet, there are many possible reasons for collecting and analyzing reliability data. There are many examples of collecting and analyzing reliability data. This could be done to assess product reliability in the field. It could be to predict product warranty costs. It could be for estimating replacement part/spares requirements.

Other examples of collecting and analyzing reliability data include:

To assess the effect of a proposed design change

To demonstrate product reliability to customers or government agencies

To compare components from multiple suppliers

To compare components from different production periods, operating environments, or materials

For improving reliability through the use of laboratory experiments.

Methodologies for doing these

There is a certain overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. The intricacies of this methodology will be the content of a two-day, in person live seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas.

Steve Wachs, who is currently a Principal Statistician at Integral Concepts, Inc., brings over 25 years of wide-ranging industry experience in both technical and management positions. To derive the benefit of hearing this experienced professional, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900409SEMINAR to register. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Calculating sample sizes

Steve will discuss the methods for estimating the reliability of subsystems and systems. He will also show how to calculate sample sizes for reliability testing and utilize reliability models to develop forecasts of future failures (e.g. warranty forecasts).

Protection of human subjects and everything relating to it is of paramount importance for those involved in or wanting to be involved in research dealing with human subjects or an individual’s private identifiable information. For these individuals, professionals and companies, it is extremely important to understand that there are federal regulations that must be followed.

There are also state statutes, institutional policies, federal guidance documents, and ethical codes that guide the conduct of the research. This is done to ensure that the research not only meets the regulatory requirements but also that it is conducted in an ethical manner, coming with adequate protections for the individuals who elect to enroll in the research or allow their information to be used for research.

Guidelines lack clarity

However, the challenge that this position presents is that the guidelines –which also provide interpretation of the regulations –are not always as clear as they might appear upon first reading them.

The Director of this seminar is the highly regarded expert on the subject, Sarah Fowler-Dixon, Education Specialist and instructor with Washington University School of Medicine. Sarah has developed a comprehensive education program for human subject research which has served as a model for other institutions.

Ways of applying concepts and theories

This two-day seminar will provide the foundation for the application, concepts and theories of clinical research.

The speaker will not only provide a refresher of the regulations; she will also provide attendees with the opportunity to discuss and learn how these regulations, ethical codes and guidance documents get applied in different situations. This information can then be used to help attendees in their day-to-day decision making when confronted with situations or questions regarding how to handle issues that do arise (e.g. a participant not showing for a scheduled appointment, an event that is unexpected occurs, someone who does not speak wishes to enroll in the study, a participant signing an outdated consent document, etc.) when conducting human subjects.

Outcomes of the seminar

The learning acquired over these two days will help attendees learn about the historical evolution of research, and current regulations and guidelines including the Common Rule, FDA regulations and HIPAA. This session will discuss site and study staff responsibilities in the conduct and reporting of research, types of studies and the regulatory requirements that apply to different study designs. It will also discuss a variety of research including genetic, drug, device, and studies that use off-site or community partners. Current examples will be used and the audience will be invited to share their experiences and information.

Undoubtedly, hiring should rate as being among the most important activities for an organization. This is so because it is through this process that the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with which to make predictions about a potential hire. These questions could relate to how well the resource can perform in the assigned role, for how long the resource could stay in the organization, and making an assessment about the person’s ability to handle more responsibilities.

Not all HR and other hiring managers could be right all the time in predicting the outcomes of their actions about a candidate; yet, a good understanding of principles of assessing the candidate, combined with proper preparation and inculcation of a little disciple will go a long way in helping them become more accurate in their predictions. When the hiring managers are not too way off their mark in predicting the attributes of a useful hire, they are more likely to get a better candidate and avoid much of the unpleasantness that a bad hire can cause.

Learn the art of predicting the usefulness and relevance of a candidate

It is to equip participants with the tools needed to design a process for selecting and promoting for any position across any industry that a two-day, in person seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Harry Brull, who is President, Laurdan Associates, Inc. and Co-Founder of BCG Consulting Group, will be this seminar’s Director.

At this seminar, Harry will explore the use of standardized instruments in designing and using simulations for maximizing return on references. This is in addition to the most often-used selection tool, the pre-employment interview.

He will also discuss other important areas of the hiring process, like defensibility and avoiding complaints from unsuccessful applicants, ways of judging a candidate’s interpersonal skills, other capabilities and motivators, and other factors which determine whether there is a good fit between the individual, the position, and the organization.

In addition, Harry will also look at adding other selection tools such as testing and simulations (job samples) to the selection tool mix, which can greatly improve prediction accuracy and provide an alternative view of candidate skills, and techniques which improve the usefulness of reference information, including eliciting vital information from sometimes reluctant sources.

The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates.

Getting Quality Assurance and Quality Control procedures and protocols right is crucial

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

The adherence to written protocols; up-to-date and suitable training of personnel

The use of reliable laboratories with excellent QA&QC systems in place

The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)

Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:

Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;

Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.

Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.

Learn the ways of doing it right from start till finish

The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas.

International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.

Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.

Understanding safety assurance cases

The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.

This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.

The problem with a supplier management program lies in the fact that the FDA audits suppliers only for finished devices. Because of this, manufacturers need to have a high degree of control over them. So, where is the problem? It lies in the FDA’s interpretation of these expectations. This keeps changing from time to time. Over the past five years, these expectations have changed considerably. Manufacturers whose devices have been around for more than five years need to thus make substantial changes into their cGMPs, hence the emphasis on the ‘c’, meaning “current”.

A seminar from the guru of supplier management

The underlying principles of supplier management will be the basis for a two-day seminar that is being organized by GlobalCompliancePanel, a reputable provider of professional trainings for the areas of regulatory compliance. The Director of this course, Betty Lane, who is the founder and President of Be Quality Associates, LLC, a consulting company that helps small and medium sized medical device and diagnostic companies implement and improve their Quality Systems, will be the Director of this seminar.

Analogous to the FDA’s thinking, European Notified Bodies also periodically update their expectations. Suppliers are now expected to remain current with a guidance document published by the Notified Body Operations Group (NBOG). This seminar will explore the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation on supplier management by expanding on them to cover other issues and techniques important in effective implementation.

Tools, templates and methods of supplier management

Betty will familiarize participants with the nitty gritty of supplier management by building upon it with the tools, templates, and methods needed for implementing an effective and efficient supplier management program. These tools consist of practical exercises which the Director will get the participants to perform.

She will also use FDA Warning Letters to illustrate the points and help the participants learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers’ location, supplier auditing techniques, and supplier issues in management review. These practical steps are aimed at fortifying and reinforcing their understanding of the topic. It will also offer the kind of interactivity with which the participants can understand the concepts threadbare.

The insight the Director will be offering into the area of supplier management will be the highlight of this seminar. This has been accumulated over years and years of experience that the Director has gained in the area of supplier management in medical devices. The Director will detail and examine the concept of risk from the perspective of both the supplier and the regulatory bodies with depth and clarity. She will also review requirements and expectations of the FDA and European Notified Bodies for supplier management, and then show how to incorporate these into the participants’ own supplier management process.

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard.

A highly meaningful and valuable learning session on how to accomplish this is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. The Director at this two-day seminar is Michael Brodsky, President of Brodsky Consultants and a Past President of the Ontario Food Protection Association (OFPA), The International Association for Food Protection (IAFP) and AOAC International. To enroll for this seminar, please log on to

A QMS that complies with the management and technical requirements of the ISO/IEC 17025:2005 standard is the core criterion for accreditation, as well as the backbone of this standard. Michael will familiarize participants with how with how laboratories can accomplish this in depth.

The Quality System Manual (QMS) is indispensable in a QMS environment because, much like its predecessor –Good Laboratory Practice (GLP) –it contains the policies that the laboratory is expected to follow to achieve Quality results. However, it is only the “what to do” component of a QMS. What laboratories also need are the “how to do it” or procedures and methods, and equally importantly, the controls or evidence that it was done properly. These are the critical requirements that documentation has to address, and are what this seminar will cover.

Doesn’t end with accreditation

Achieving accreditation is only half the job done, because once this has been done, the tougher part –that of maintaining the QMS –begins. The high number of non-conformances cited during the subsequent biannual audits is proof of this fact. This seminar will explain how to maintain the QMS in the long run to the satisfaction of regulatory authorities, as well as to meet the laboratory’s needs.

Those in Laboratory Management/Supervision, Laboratory Quality Development, Laboratory Quality Management, Laboratory Quality Control and Analytical support need to ask critical questions at the time of embarking on the process of developing documents and records that meet the requirements of ISO 17025, such as:

Why should we want to become accredited?

Where do we start?

If our laboratory is already accredited, how do we ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Michael will help participants at this seminar develop the critical thinking that is essential for developing documents and records in compliance with ISO 17025.